Trial record 1 of 1 for: NCT01418859

Previous Study | Return to List | Next Study

Clinical Study in Post-operation Treatment of Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01418859

Recruitment Status : Unknown

Verified March 2012 by Liu Zi, Health Science Center of Xi'an Jiaotong University.
Recruitment status was: Recruiting

First Posted : August 17, 2011

Last Update Posted : March 21, 2012

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Liu Zi, Health Science Center of Xi'an Jiaotong University

Study Description

Brief Summary:

The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Condition or disease
Cervical Cancer

Detailed Description:

Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	183 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer
Study Start Date :	August 2011
Estimated Primary Completion Date :	December 2012
Estimated Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
radiation therapy only Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive radiation therapy only. radiation therapy regimen: 3D-CRT pelvic radiation, 95%CTV DT 45Gy/25f. Radiation field include tumor bed and regional lymph nodes area. Upper border: branching of abdominal aorta. The radiation fields go down along the iliac vessels (including regions of 7mm out of the iliac vessels) and include the tumor bed region. Lower border: the inferior margin of obturator foramen.
concurrent chemoradiotherapy Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy. radiation therapy regimen is the same with radiation therapy only group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy.
concurrent and additional chemotherapy Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy, and additional chemotherapy after concurrent treatment. radiation therapy regimen is the same with radiation therapy group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy. Additional chemotherapy regimen is the same with concurrent chemotherapy, and will be carry out in the 4th and 8th week after radiation therapy.

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	20 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion.

Criteria

Inclusion Criteria:

patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;
squamous carcinoma;
age<70;
Gynecologic Oncology Group (GOG):0-2.

Exclusion Criteria:

negative nodes,surgical margin,and/or parametrium;
No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418859

Contacts

Layout table for location contacts

Contact: Liu Zi, M.D	86-18991232167	liuzmail@163.com
Contact: Wang Tao, M.D	86-18991232386	taowangmd@163.com

Locations

Layout table for location information

China, Shanxi
Xi'an Jiaotong University College of Medicine	Recruiting
Xi'an, Shanxi, China, 710061
Contact: Zi Liu, M.D 086-18991232167 18991232167@189.cn
Contact: Tao Wang, M.D 086-18991232386 18991232386@189.cn
Sub-Investigator: Tao Wang, M.D

Sponsors and Collaborators

Health Science Center of Xi'an Jiaotong University

Investigators

Layout table for investigator information

Study Director:	Chen M W, M.D	Affiliated Hospital of Medical College of Xo'an Jiaotong University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sun W, Wang T, Shi F, Wang J, Wang J, Hui B, Zhang Y, Lu J, Chen H, Liu Z. Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy. BMC Cancer. 2015 May 4;15:353. doi: 10.1186/s12885-015-1355-1.

Layout table for additonal information

Responsible Party:	Liu Zi, Profesor, Health Science Center of Xi'an Jiaotong University
ClinicalTrials.gov Identifier:	NCT01418859
Other Study ID Numbers:	GCR-01
First Posted:	August 17, 2011 Key Record Dates
Last Update Posted:	March 21, 2012
Last Verified:	March 2012

Keywords provided by Liu Zi, Health Science Center of Xi'an Jiaotong University:


cervical cancer postoperation chemotherapy radiotherapy

Additional relevant MeSH terms:

Layout table for MeSH terms

Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases	Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases

To Top